MELBOURNE - Opthea Limited (ASX/NASDAQ: OPT), a clinical-stage biopharmaceutical company, has announced the establishment of a Medical Advisory Board (MAB) to guide its development of treatments for retinal diseases such as wet age-related macular degeneration (wet AMD (NASDAQ:AMD)). The MAB, chaired by Arshad M. Khanani, MD, MA, FASRS, includes 10 retina specialists from various countries, including the US, Argentina, Australia, China, France, Germany, and Israel.
The advisory board's formation is a strategic move for Opthea as it approaches a critical phase in its clinical trials. The company is preparing for Phase 3 topline data read-out of its two pivotal trials of sozinibercept in wet AMD, with COAST expected in early Q2 2025 and ShORE in mid-2025. These trials are vital for the company's Biologics License Application (BLA) and market preparation strategies.
The MAB members are renowned experts in the field of retinal diseases, each bringing significant clinical and research experience. Their expertise will inform Opthea's efforts to address the unmet medical needs of patients with retinal diseases. The company's CEO, Frederic Guerard, PharmD, expressed gratitude for the support from these experts and emphasized the company's commitment to advancing therapeutic innovations in the retinal community.
Opthea's lead product candidate, sozinibercept, is being evaluated for its potential to improve efficacy and deliver superior vision gains in combination with standard-of-care anti-VEGF-A therapies. The formation of the MAB is a key step in the company's strategy to leverage expert insights for its clinical development programs.
In other recent news, Optiva Inc., renowned for its cloud-native billing and revenue management software for the telecom industry, has secured the ISO 27001 Certification. This internationally recognized certification is a testament to Optiva's commitment to information security, cybersecurity, and privacy protection.
Achieving this certification indicates that Optiva's operations and protocols effectively mitigate risks, ensure data confidentiality, and proactively address information security threats. This development is a significant step in Optiva's ongoing efforts to maintain and enhance information security for its clients in the telecommunications industry.
In parallel, Opthea Ltd. has received an optimistic outlook from Oppenheimer, the investment firm. Following a meeting with Opthea's management team and a virtual Key Opinion Leader event, Oppenheimer raised the biotechnology company's price target from $16 to $18, while maintaining an Outperform rating.
Opthea has successfully completed enrollment for its COAST trial and is on track to finish the ShORe trial in the second quarter of 2024. Both these global Phase 3 trials are evaluating Opthea's product candidate sozinibercept for its effectiveness in treating wet age-related macular degeneration. The anticipation for topline data from these trials is set for the middle of 2025.
InvestingPro Insights
As Opthea Limited gears up for critical Phase 3 clinical trials, insights from InvestingPro highlight some financial metrics and considerations that investors may find pertinent. With a market capitalization of $272.03 million, Opthea is maneuvering through a challenging phase characterized by cash burn and anticipated declines in both sales and net income for the current year.
InvestingPro Tips suggest that the company is rapidly depleting its cash reserves and analysts do not expect it to be profitable this year. This could be particularly relevant given the high costs associated with late-stage clinical trials and regulatory approvals. Moreover, with Opthea's revenue growth at 60.87% in the last twelve months as of Q2 2024, there is evidence of significant development in its financial performance, although this is juxtaposed with a substantial operating income margin deficit of -42247.77%.
From a valuation standpoint, Opthea is trading at a high revenue valuation multiple, which could reflect investor optimism about the company's growth prospects or potential market share in the lucrative field of retinal disease treatments. However, the company does not pay dividends, which may influence the investment decisions for those seeking income-generating assets.
For readers looking to delve deeper into Opthea's financial health and future prospects, additional InvestingPro Tips are available, providing a comprehensive analysis of the company's financials and market potential. To access these insights and more, visit InvestingPro and consider using the coupon code PRONEWS24 to get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription. There are currently 9 additional InvestingPro Tips available to subscribers that could further inform investment decisions regarding Opthea Limited.
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